UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047559 |
|---|---|
| Receipt number | R000052810 |
| Scientific Title | Management of advanced esophageal cancer patients received chemotherapy using early ctDNA dynamics |
| Date of disclosure of the study information | 2022/04/25 |
| Last modified on | 2023/03/22 18:00:54 |
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Basic information
Public title
Management of advanced esophageal cancer patients received chemotherapy using early ctDNA dynamics
Acronym
CHANGE-ES01 study
Scientific Title
Management of advanced esophageal cancer patients received chemotherapy using early ctDNA dynamics
Scientific Title:Acronym
CHANGE-ES01 study
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This prospective randomized controlled trial will evaluate the clinical utility of early treatment change based on early circulating tumor DNA (ctDNA) dynamics during chemotherapy for advanced esophageal cancer patients. Treatment efficacy will be evaluated by the change of ctDNA level before and after the initial cycle of chemotherapy using digital PCR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
2-year overall survival rates
Key secondary outcomes
1) Progression free survival rates
2) ctDNA dynamics and change of tumor burden
3) Quality of life, Quality-adjusted life years
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Patients without ctDNA decrease before and after the initial cycle of chemotherapy (post-/pre-ctDNA: equal or more than 10%): treatment change based on the efficacy evaluation of chemotherapy using conventional diagnostic methods (Group A)
Interventions/Control_2
Patients without ctDNA decrease before and after the initial cycle of chemotherapy (post-/pre-ctDNA: equal or more than 10%): change to the next-line treatment based on the early ctDNA dynamics (Group B)
Interventions/Control_3
Patients with ctDNA decrease before and after the initial cycle of chemotherapy (post-/pre-ctDNA: less than10%): treatment change based on the efficacy evaluation of chemotherapy using conventional diagnostic methods (non-randomized; Group C)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with Stage III/IV or recurrent esophageal cancer planning to chemotherapy with
docetaxel, cisplatin and 5-FU or CDDP and 5-FU as the first line therapy
2) Histologically diagnosed esophageal carcinoma
3) Primary tumor located in thoracic esophagus. Tumor which is centrally located more than 2 cm below of the esophago-gastric junction is ineligible
4) ECOG performance status: 0-2
5) More than 2 treatments regimens are remained
6) Written informed consent
Key exclusion criteria
1) Synchronous malignancies except for early cancer which will not affect prognosis.
2) Patients with active infection with fever requiring a systematic therapy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | S |
| Last name | Nishizuka |
Organization
Iwate Medical University Institute for Biomedical Sciences
Division name
Division of Biomedical Research & Development
Zip code
028-3694
Address
1-1-1 Idai-dori, Yahaba, Iwate, Japan
TEL
019-651-5111
snishizu@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Iwaya |
Organization
Iwate Medical University School of Medicine
Division name
Department of Surgery
Zip code
028-3695
Address
2-1-1 Idai-dori, Yahaba, Iwate
TEL
019-613-7111
Homepage URL
tiwaya@iwate-med.ac.jp
Sponsor or person
Institute
Division of Biomedical Research and Development, Institute of Biomedical Sciences, Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Quantdetect, Inc,
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Society for the promotion of science,
Chugai Pharmaceutical
IRB Contact (For public release)
Organization
Iwate Medical University
Address
2-1-1 Idai-dori, Yahaba, Japan
Tel
0196137111(ext.5532)
kenkyu-rinri@j.iwate-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
岩手医科大学付属病院（岩手県）、県立久慈病院（岩手県）、県立宮古病院（岩手県）、県立釜石病院（岩手県）、八戸赤十字病院（青森県）、県立千厩病院（岩手県）、県立二戸病院（岩手県）、かづの厚生病院（秋田県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 22 | Day |
Last modified on
| 2023 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052810
